On November 5, 2015 Medigene AG (MDG1, Frankfurt, Prime Standard) reported that early clinical data of its dendritic cell (DC) vaccines will be presented at the upcoming ASH (Free ASH Whitepaper) Annual Meeting taking place from December 5 – 8, 2015 in Orlando, Florida, USA, by its partner Oslo University Hospital, Norway (Press release, MediGene, NOV 5, 2015, View Source [SID:1234508023]). The clinical data were collected in an ongoing compassionate use[1] programme conducted by the Oslo University Hospital under the responsibility of Prof. Gunnar Kvalheim. The poster presentation shows data from patients with acute myeloid leukaemia (AML) and is entitled "AML Patients in Minimal Residual Disease Vaccinated with a Novel Generation of Fast Dendritic Cells Expressing WT-1 and PRAME Mount Specific Immune Responses That Relate to Clinical Outcome". The poster will be presented on December 7, 2015 at 6 PM – 8 PM (local time).

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The Oslo University Hospital has an agreement with Medigene for the use of Medigene`s new generation DC vaccines for their ongoing academic clinical studies. Medigene’s DC vaccines are produced according to GMP guidelines at the Department of Cellular Therapy at the Oslo University Hospital. Acute myeloid leukaemia is Medigene’s lead indication in its DC vaccine programme.

Link to the Abstract: View Source

About Medigene’s DC vaccines: The platform for the development of antigen-tailored DC vaccines is the most advanced platform of the three highly innovative and complementary immunotherapy platforms of Medigene Immunotherapies. Currently, Medigene evaluates its DC vaccines in a company-sponsored phase I/II clinical trial in acute myeloid leukaemia (AML). Further studies utilizing Medigene’s DC vaccine technology include two ongoing clinical investigator-initiated trials: a clinical phase I/II trial in AML at the Ludwig-Maximilian University Hospital Großhadern, Munich, and a clinical phase II trial in prostate cancer at Oslo University Hospital. Moreover, a compassionate use programme is being conducted at the Department of Cellular Therapy at Oslo University Hospital.

Dendritic cells (DCs) are the most potent antigen presenting cells of our immune system. Their task is to take up, process and present antigens on their cell surface, which enables them to activate antigen-specific T cells for maturation and proliferation. This way T cells can recognise and eliminate antigen-bearing tumour cells. Dendritic cells can also induce natural killer cells (NK cells) to attack tumour cells. The team of Medigene Immunotherapies GmbH’s scientists has developed new, fast and efficient methods for generating dendritic cells ex-vivo, which have relevant characteristics to activate both T cells and NK cells. The DC vaccines are developed from autologous (patient-specific) precursor cells, isolated from the patient’s blood, and can be loaded with tumor-specific antigens to treat different types of cancer. Medigene’s DC vaccines are in development for the treatment of minimal residual disease or use in combination therapies.

On November 5, 2015 Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), reported that more than 45 abstracts featuring eight of its approved or investigational medicines will be presented during the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting from December 5-8 in Orlando (Press release, Genentech, NOV 5, 2015, View Source [SID:1234508022]). The abstracts include more than 15 oral presentations across a broad range of molecular targets and combinations, as well as different clinical endpoints that Genentech is exploring in various blood diseases and lines of treatment.

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"Our data at ASH (Free ASH Whitepaper) this year showcase the evolution of our hematology portfolio and represent potential future approaches to helping people with blood cancers and blood disorders," said Sandra Horning, M.D., chief medical officer and head of Global Product Development. "We’re particularly excited about studies evaluating new combinations with Gazyva and venetoclax, as well as studies examining the potential clinical significance of minimal residual disease negativity."

Data for Gazyva include results from combination studies such as the Phase IIIb GREEN study and the pivotal CLL11 and GADOLIN studies. GREEN results will include data for Gazyva in combination with bendamustine in previously untreated chronic lymphocytic leukemia (CLL). Genentech will also share updated results from the Phase III CLL11 study, which formed the basis of the Gazyva approval in previously untreated CLL in combination with chlorambucil, and further data from the pivotal Phase III GADOLIN study for the investigational use of Gazyva in patients with indolent non-Hodgkin’s lymphoma (NHL) that is refractory to Rituxan (rituximab)-based treatment, that add to the positive results presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June this year.

Genentech will also present findings from multiple studies that suggest a potential role for minimal residual disease (MRD)-negativity in the treatment of certain blood cancers. In collaboration with AbbVie, Genentech will share new data for investigational medicine venetoclax as a monotherapy or in combinations across a number of blood cancers, including CLL, NHL, multiple myeloma (MM) and acute myeloid leukemia (AML). Data will also be shown for investigational medicine ACE910, which was recently granted breakthrough therapy designation by the U.S. Food and Drug Administration (FDA) for the prophylactic treatment of people who are 12 years or older with hemophilia A with factor VIII inhibitors.

The table below contains key abstracts featuring Genentech medicines that will be presented. Follow Genentech on Twitter via @Genentech and keep up to date with ASH (Free ASH Whitepaper) Annual Meeting news and updates by using the hashtag #ASH2015.

Separately, the FDA has accepted for priority review the company’s supplemental Biologics License Application (sBLA) for Gazyva in the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to a rituximab-containing regimen, based on GADOLIN study results. Marketing applications for Gazyva have also been submitted to other health authorities, including the European Medicines Agency, for approval consideration in the treatment of patients with FL who did not respond or who progressed during or up to six months after treatment with rituximab or a rituximab-containing regimen. In addition, AbbVie has submitted a New Drug Application (NDA) for venetoclax to the FDA under breakthrough therapy designation, based in part on results of the pivotal Phase II M13-982 study evaluating venetoclax in people with relapsed/refractory CLL harboring the 17p deletion. Genentech and AbbVie announced positive top-line results from this study earlier this year.

Gazyva Indication

Gazyva is a prescription medicine used with the chemotherapy drug, chlorambucil, to treat chronic lymphocytic leukemia (CLL) in adults who have not had previous CLL treatment.

Important Safety Information

Patients must tell their doctor right away about any side effects they experience. Gazyva can cause side effects that can become serious or life threatening, including:

Hepatitis B Virus (HBV): Hepatitis B can cause liver failure and death. If a patient has had history of hepatitis B infection, Gazyva could cause it to return. Patients should not receive Gazyva if they have active hepatitis B liver disease. The patient’s doctor or healthcare team will need to screen for hepatitis B before, and monitor the patient for hepatitis during and after, treatment with Gazyva. Sometimes this will require treatment for hepatitis B. Symptoms of hepatitis include: worsening of fatigue and yellow discoloration of skin or eyes.

Progressive Multifocal Leukoencephalopathy (PML): PML is a rare and serious brain infection caused by a virus. PML can be fatal. A patient’s weakened immune system could put the patient at risk. The patient’s doctor will watch for symptoms. Symptoms of PML include: confusion, difficulty talking or walking, dizziness or loss of balance, and vision problems.

Additional possible serious side effects of Gazyva:

Patients must tell their doctor right away about any side effects they experience. Gazyva can cause side effects that may become severe or life threatening, including:

Infusion Reactions: These side effects may occur during or within 24 hours of any Gazyva infusion. Some infusion reactions can be serious, including, but not limited to, severe allergic reactions (anaphylaxis), acute life-threatening breathing problems, or other life-threatening infusion reactions. If a patient has a reaction, the infusion is either slowed or stopped until the patient’s symptoms are resolved. Most patients are able to complete infusions and receive medication again. However, if the infusion reaction is serious, the infusion of Gazyva will be permanently stopped. The patient’s healthcare team will take steps to help lessen any side effects the patient may have to the infusion process. The patient may be given medicines to take before each Gazyva treatment. Signs of infusion reactions may include: dizziness, nausea, chills, fever, vomiting, diarrhea, breathing problems, and chest pain.

Tumor Lysis Syndrome (TLS): Gazyva works to break down cancer cells quickly. As cancer cells break apart, their contents are released into the blood. These contents may cause damage to organs and the heart, and may lead to kidney failure requiring the need for dialysis treatment. TLS, including death, has been reported in patients receiving Gazyva. The patient’s doctor may prescribe medication to help prevent TLS. The patient’s doctor will also conduct regular blood tests to check for TLS. Symptoms of TLS may include nausea, vomiting, diarrhea, and tiredness.

Infections: While a patient is taking Gazyva, the patient may develop infections. Some of these infections may be severe. Fatal infections have been reported, so the patient should be sure to talk to the doctor if the patient thinks the patient has one. Patients with active infection should not be treated with Gazyva. Infections may continue even after the patient stops taking Gazyva. The patient’s doctor may prescribe medications to help prevent infections. Symptoms of infection include fever and cough.
Low White Blood Cell Count : When a patient has an abnormally low count of infection-fighting white blood cells, it is called neutropenia. While the patient is taking Gazyva, the patient’s doctor will do blood work to check the patient’s white blood cell counts. Neutropenia can develop during or after treatment with Gazyva. It may also last for more than one month. If a patient’s white blood cell count is low, the patient’s doctor may prescribe medication to help prevent infections.

Low Platelet Count: Platelets help stop bleeding or blood loss. Gazyva may reduce the number of platelets the patient has in the blood. This may affect the clotting process. While the patient is taking Gazyva, the patient’s doctor will do blood work to check the patient’s platelet count.
Most common side effects of Gazyva

The most common side effects of Gazyva are infusion reactions, low white blood cell counts, low platelet counts, low red blood cell counts, fever, cough, nausea, and diarrhea.

Before receiving Gazyva, patients should talk to their doctor about:

Immunizations: Before receiving Gazyva therapy, the patient should tell the patient’s healthcare provider if the patient has recently received or is scheduled to receive a vaccine. Patients who are treated with Gazyva should not receive live vaccines.

Pregnancy: A patient should tell the doctor if the patient is pregnant, plans to become pregnant, or is breastfeeding. Gazyva may harm the unborn baby. Mothers who have been exposed to Gazyva during pregnancy should discuss the safety and timing of live virus vaccinations for their infants with their child’s healthcare providers. It is not known if Gazyva may pass into the patient’s breast milk. The patient should speak to the doctor about using Gazyva if the patient is breastfeeding.

Patients must tell their doctor about any side effects.

These are not all of the possible side effects of Gazyva. For more information, patients should ask their doctor or pharmacist.

Gazyva is available by prescription only.

Report side effects to the FDA at (800) FDA-1088, or View Source Report side effects to Genentech at (888) 835-2555.

Please visit View Source for the full Prescribing Information, including Boxed WARNINGS, for additional Important Safety Information.

Rituxan Indications

Rituxan (rituximab) is indicated for the treatment of patients with:

Relapsed or refractory, low-grade or follicular, CD20-positive, B-cell NHL as a single agent
Previously untreated follicular, CD20-positive, B-cell NHL in combination with first-line chemotherapy and, in patients achieving a complete or partial response to Rituxan in combination with chemotherapy, as single-agent maintenance therapy
Non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL, as a single agent, after first-line CVP chemotherapy
Previously untreated diffuse large B-cell, CD20-positive NHL in combination with CHOP or other anthracycline-based chemotherapy regimens
Previously untreated and previously treated CD20-positive CLL in combination with fludarabine and cyclophosphamide (FC)
Rituxan is not recommended for use in patients with severe, active infections.

Important Safety Information:

Rituxan can cause serious side effects that can lead to death, including:

Infusion Reactions: may occur during or within 24 hours of the infusion. The patient’s doctor should give the patient medicines before their treatment. Symptoms can include hives, rash, itching, facial or oral swelling, sudden cough, shortness of breath, difficulty breathing, weakness, dizziness, feeling faint, racing heart or chest pain.
Severe Skin and Mouth Reactions: symptoms can include painful sores, ulcers, or blisters on the skin, lips or mouth; peeling skin; rash; or pustules.

Hepatitis B Virus (HBV) Reactivation: may cause serious liver problems including liver failure and death. If patients have had hepatitis B or are carriers of HBV, receiving Rituxan could cause the virus to become an active infection again. Patient should not receive Rituxan if they have active HBV liver disease. The patient’s doctor will do blood tests to check for HBV infection prior to treatment and will monitor the patient during and for several months following their treatment.
Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain infection that can lead to severe disability and death and for which there is no known prevention, treatment or cure. Symptoms can include difficulty thinking, loss of balance, changes in speech or walking, weakness on one side of the body or blurred or lost vision.
What are the additional possible serious side effects of Rituxan?

Patients must tell their doctor right away about any side effects they experience. Rituxan can cause serious side effects that can lead to death, including:

Tumor Lysis Syndrome (TLS): may cause kidney failure and the need for dialysis treatment, abnormal heart rhythm and can lead to death. The patient’s doctor may give the patient medicines before their treatment to help prevent TLS.
Serious Infections: can happen during and after treatment and can lead to death. These infections may be bacterial, fungal or viral. Symptoms can include fever; cold or flu symptoms; earache or headache; pain during urination; white patches in the mouth or throat; cuts or scrapes that are red, warm, swollen or painful.
Heart Problems: symptoms can include chest pain and irregular heartbeats that may require treatment. The patient’s doctor may need to stop their treatment.
Kidney Problems: the patient’s doctor should do blood tests to check how well the patient’s kidneys are working.
Stomach and Serious Bowel Problems: can include blockage or tears in the bowel that can lead to death. Stomach area pain during treatment can be a symptom.
Low Blood Cell Counts: the patient’s blood cell counts may be monitored during treatment.
The most common side effects of Rituxan are infusion reactions, chills, infections, body aches, tiredness and low white blood cells.

Patients must tell their doctor if they are pregnant, plan to become pregnant or are breastfeeding. It is not known if Rituxan may harm the patient’s unborn baby or pass into the patient’s breast milk. Women should use birth control while using Rituxan and for 12 months after treatment.

Patients must tell their doctor about any side effect that bothers them or that does not go away.

These are not all of the possible side effects of Rituxan. For more information, patients should ask their doctor or pharmacist.

Report side effects to the FDA at (800) FDA-1088 or View Source Report side effects to Genentech at (888) 835-2555.

Please see the Rituxan full Prescribing Information, including Most Serious Side Effects, for additional important safety information at View Source

On November 5, 2015 Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN), a clinical stage biopharmaceutical company developing next generation therapeutics for the treatment of cancer, reported that interim clinical data from an ongoing Phase IIa study of its novel anti-cancer drug candidate, Archexin, will be presented on Friday, November 6, 2015 at the 14th International Kidney Cancer Symposium in Miami, Florida (Filing, 8-K, Rexahn, NOV 5, 2015, View Source [SID:1234508020]).

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"We are excited to present interim data from the ongoing Phase IIa clinical trial showing that Archexin, in combination with everolimus (Afinitor), appears to be safe and well tolerated at the doses tested to date. We have also noted early evidence of clinical activity at low doses in patients with metastatic kidney cancer," commented Peter D. Suzdak, Chief Executive Officer. "We look forward to completing the randomized, open-label, 2-arm dose expansion study of Archexin in combination with everolimus versus everolimus alone in order to further evaluate Archexin in metastatic renal cell carcinoma."

Archexin Clinical Data

Interim data from the Phase IIa Archexin clinical trial will be presented on Friday, November 6, 2015 by study investigators, Drs. S. Tagawa, G. Chatta and N. Agarwal in a poster presentation entitled "RX-0201, An Anti-Sense Targeting AKT-1 to Treat Metastatic Renal Cancer – Preliminary Phase IIa Data."

The interim results show that at the dose levels tested to date, Archexin appeared to be safe and well tolerated. The most commonly reported adverse events in the patients taking both Archexin and everolimus included: thrombocytopenia, mouth ulcerations, decreased weight, facial edema, and hyponatremia. To date, none of these adverse events has been dose limiting.

Early evidence of the potential clinical activity of Archexin in combination with everolimus has been observed. Among the patients enrolled in the study, two patients experienced stable disease, which has persisted for 170 and 334 days (as of October 28, 2015). In addition, at the lowest dose tested one patient experienced a 15% reduction in tumor size, as compared to a baseline CT scan taken prior to treatment with Archexin and everolimus.

Scott Tagawa, MD, MS, Medical Director, Genitourinary Oncology Research Program, Associate Professor of Clinical Medicine and Urology, Division of Hematology & Medical Oncology, Weill Cornell Medical College, commented, "The treatment of patients with metastatic RCC remains a significant unmet medical need and the early evidence supporting the potential clinical benefit of Archexin is therefore very promising. With a unique mechanism of action targeting a well validated cancer pathway (Akt-1 suppression), it is possible that Archexin in combination with everolimus could have a two-fold effect in the treatment of RCC, both by inhibiting the growth and proliferation of RCC, but also potentially by overcoming resistance to mTOR inhibitors. I look forward to further evaluation of this promising approach."

The ongoing Phase IIa clinical study is designed to evaluate the efficacy of Archexin in combination with everolimus (Afinitor) to treat metastatic RCC patients and is being conducted in two stages. Stage 1 is an open-label, dose-escalation study designed to identify a safe and tolerable dose of Archexin when given in combination with everolimus. Stage 2 is a randomized, open-label, 2-arm dose expansion study of Archexin in combination with everolimus versus everolimus alone to determine safety and efficacy of the combination.

In Stage 1, escalating doses of Archexin of 125, 200 and 250 mg/m2/day are administered by continuous IV infusion for 14 days followed by 1 week of rest. Based on previous clinical data, the target dose of Archexin is anticipated to be no more than 250 mg/m2 per day. Patient assessments include safety, pharmacokinetics, laboratory and physical exams. Once the maximum tolerated dose of Archexin in combination with everolimus has been determined, thirty RCC patients will be randomized to receive either Archexin in combination with everolimus, or everolimus alone, in a ratio of 2:1.

The primary endpoint of Stage 2 is the percentage of progression free patients following eight cycles of therapy. Patients are scanned (CT or MRI) for the assessment of tumor progression after every 2 cycles of therapy. Secondary endpoints include pharmacokinetic profile, incidence of adverse events, changes in clinical laboratory tests and vital signs over time, tumor response, duration of response, time to response, and response rate. Exploratory endpoints include blood levels of AKT pathway biomarkers, tumor apoptosis biomarkers, or other relevant biomarkers.

In preclinical studies, Archexin has been shown to inhibit the growth of human renal cell carcinoma (RCC) cells in tissue culture. Archexin has also been shown to exhibit an additive anti-tumor effect when combined with other cancer drugs in inhibiting the growth of human RCC cells in tissue culture.

About Archexin

Archexin is a unique anti-sense drug candidate that specifically inhibits the cancer cell signaling protein Akt-1. Archexin is the only specific inhibitor of Akt-1 in clinical development. The activated form of Akt-1, which is involved in cancer cell growth, survival, angiogenesis, and drug resistance, has been shown to be present or elevated in more than 12 different human cancer cell lines, including pancreatic and renal cell carcinoma. By inhibiting Akt-1, Archexin has been shown to both inhibit the growth of renal cell carcinoma cell lines and exhibit a longer survival benefit in the human renal cell carcinoma animal xenograft model. Thus, while Akt-1 is a very specific anti-cancer target, it may have broad therapeutic potential across multiple types of cancer.

Archexin has completed a Phase I clinical trial in cancer patients with solid tumors and was shown to be safe and well tolerated. The dose-limiting toxicity was Grade 3 fatigue. In a small Phase IIa trial in advanced pancreatic cancer patients, Archexin in combination with gemcitabine was shown to be safe and well tolerated and showed a preliminary efficacy signal with a median survival of 9.1 months in evaluable patients.

Metastatic RCC represents an attractive market opportunity with an estimated annual incidence of 90,000 patients worldwide. Metastatic RCC patients receiving standard of care treatment have a poor prognosis with an overall survival of less than 2 years. Rexahn has received U.S. Food and Drug Administration (FDA) Orphan Drug Designation for Archexin for metastatic RCC as well as four other cancers.

On November 05, 2015 MorphoSys AG (FSE: MOR; Prime Standard Segment; TecDAX, OTC: MPSYY) reported upcoming presentations of data on the Company’s proprietary programs at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, being held December 5-8, 2015 in Orlando, Florida (Press release, MorphoSys, NOV 5, 2015, View Source [SID:1234508019]). Presentations will feature pre-clinical and clinical data for MorphoSys’s proprietary programs MOR208 and MOR202.

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"We believe the promising new pre-clinical and clinical data being presented for our proprietary portfolio will further demonstrate the potential of MOR208 and MOR202 as important treatment options for patients with B-cell malignancies and multiple myeloma, respectively," commented Dr. Arndt Schottelius, Chief Development Officer of MorphoSys AG. "We intend to start additional clinical trials of MOR208 in combination regimens to assess the potential benefit of such regimens for patients with CLL and DLBCL."

Phase IIa Study of Single-Agent MOR208 in Patients with Relapsed or Refractory B-cell Non-Hodgkin’s Lymphoma

The poster presentation will include updated clinical results from the MOR208 monotherapy trial in adult patients with relapsed/refractory NHL.

Abstract #1528

Poster session 624: Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models

Date: Saturday, December 5, 2015, 5:30pm – 7:30pm EST (11:30pm CET, 10:30pm GMT)

A Phase II Study of the Fc Engineered CD19 Antibody MOR208 in Combination with Lenalidomide for Patients with Chronic Lymphocytic Leukemia (CLL)

The poster presentation will include first safety and efficacy results from the ongoing trial of MOR208 in combination with lenalidomide.

Abstract #2953

Poster session 642: CLL: Therapy, excluding Transplantation

Date: Sunday, December 6, 2015, 6:00pm – 8:00pm EST (0:00 am CET (Dec. 7), 11:00pm GMT)

Phase I/IIa Study of the Human Anti-CD38 Antibody MOR202 (MOR03087) in Relapsed or Refractory Multiple Myeloma

The poster presentation will include updated safety and efficacy results from the ongoing MOR202 dose-escalation study in multiple myeloma patients. Data will be presented from the highest dose cohort of MOR202 as monotherapy, as well as from the first two cohorts of patients receiving MOR202 in combination with lenalidomide and pomalidomide.

Abstract #3035

Session Name: 653. Myeloma: Therapy, excluding Transplantation

Date: Sunday, December 6, 2015, 6:00pm – 8:00pm EST (0:00 am CET (Dec. 7), 11:00pm GMT)

MOR202, a Human Anti-CD38 Monoclonal Antibody, Mediates Potent Tumoricidal Activity In Vivo and Shows Synergistic Efficacy in Combination with Different Antineoplastic Compounds

Abstract #3015

Poster session 652: Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy

Date: Sunday, December 6, 2015, 6:00pm – 8:00pm EST (0:00 am CET (Dec. 7), 11:00pm GMT)

Lenalidomide enhances MOR202 dependent macrophage-mediated effector functions via the vitamin D pathway

Abstract #2203

Poster session 201: Granulocytes, Monocytes and Macrophages

Date: Sunday, December 6, 2015, 6:00pm – 8:00pm EST (0:00 am CET (Dec. 7), 11:00pm GMT)

Additional information can be found at www.hematology.org, including the abstracts.

On November 5, 2015 Epizyme, Inc. (NASDAQ:EPZM), a clinical stage biopharmaceutical company creating novel epigenetic therapies for cancer patients, reported that data from the ongoing phase 1 study of tazemetostat (EPZ-6438) will be presented during the American Society of Hematology (ASH) (Free ASH Whitepaper) Meeting being held December 5 – 8 in Orlando, Florida (Press release, Epizyme, NOV 5, 2015, View Source [SID:1234508017]). Tazemetostat is a first-in-class EZH2 inhibitor that is currently being studied in relapsed or refractory B-cell Non-Hodgkin Lymphoma (NHL) and solid tumors. The company will also present an update on its phase 1 study of pinometostat (EPZ-5676) in adult patients with MLL-r acute leukemia and a preliminary report on its phase 1 study of pinometostat in children with MLL-r acute leukemia.

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"Tazemetostat has demonstrated significant potential in early clinical testing in patients with NHL," said Peter Ho, M.D., Ph.D., Chief Medical Officer, Epizyme. "Based on the clinical activity and acceptable safety profile observed with tazemetostat, we believe there is potential for tazemetostat to treat both late-stage NHL as a monotherapy and also earlier-stage disease as a combination therapy. We are continuing to advance tazemetostat in a registration-supporting Phase 2 study in five subtypes of relapsed or refractory NHL, and look forward to beginning investigation of tazemetostat as a combination agent in patients with NHL in the first half of 2016."

Planned presentations:

Phase 1 Study of Tazemetostat (EPZ-6438), an Inhibitor of Enhancer of Zeste-Homolog 2 (EZH2): Preliminary Safety and Activity in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) Patients
Speaker: Vincent Ribrag, M.D., Institut Gustave Roussy, Villejuif, France.
Session title: 624. Lymphoma: Therapy with Biologic Agents, excluding Pre-Clinical Models: Biologic Agents in B Cell Lymphoma (Oral Session)
Presentation time: Monday, December 7, 2015 at 8:00am ET

A Phase 1 Study of the DOT1L Inhibitor Pinometostat, EPZ-5676, in Advanced Leukemia: Safety, Activity and Evidence of Target Inhibition
Presenter: Eytan M. Stein, M.D., Memorial Sloan Kettering Cancer Center
Session title: Poster Session II
Presentation time: Sunday, December 6, 2015 from 6:00 – 8:00pm ET

Preliminary Report of the Phase 1 Study of the DOT1L Inhibitor Pinometostat (EPZ 5676) in Children with MLL-r Acute Leukemia: Safety, Exposure and Evidence of Target Inhibition
Presenter: Neerave Shukla, M.D., Memorial Sloan Kettering Cancer Center
Session title: Poster Session III
Presentation time: Monday, December 7, 2015 from 6:00 – 8:00pm ET

About EZH2 in Cancer

EZH2 is a histone methyltransferase (HMT) that is increasingly understood to play a potentially oncogenic role in a number of cancers. These include Non-Hodgkin Lymphoma, INI1-deficient cancers such as malignant rhabdoid tumors, epithelioid sarcomas and synovial sarcoma; and a range of other solid tumors.

About Tazemetostat

Epizyme is developing tazemetostat for the treatment of Non-Hodgkin Lymphoma patients and patients with INI1-deficient solid tumors. Tazemetostat is a first-in-class small molecule inhibitor of EZH2 created by Epizyme using its proprietary product platform. In some human cancers, aberrant EZH2 enzyme activity results in misregulation of genes that control cell proliferation resulting in the rapid and unconstrained growth of tumor cells. Tazemetostat is the WHO International Non-Proprietary Name (INN) for compound EPZ-6438.

Additional information about this program, including clinical trial information, may be found here: View Source

About Pinometostat

Epizyme is developing pinometostat, a small molecule inhibitor of DOT1L created with Epizyme’s proprietary product platform, for the treatment of patients with acute leukemia in which the MLL gene is rearranged due to a chromosomal translocation (MLL-r). Due to these rearrangements, DOT1L is misregulated, resulting in the increased expression of genes causing leukemia. Pinometostat is the WHO International Non-Proprietary Name (INN) for compound EPZ-5676.

Epizyme believes that pinometostat was the first HMT inhibitor to enter human clinical development. Epizyme initiated a phase 1b study of pinometostat in pediatric patients with MLL-r in May 2014. Additional information about this ongoing phase 1 study can be found here:
View Source

Pinometostat has been granted orphan drug designation for the treatment of acute lymphoblastic leukemia (ALL) and acute myeloid leukemia (AML) by the Food and Drug Administration in the U.S. and by the European Commission in Europe.

Epizyme retains all U.S. rights to pinometostat and has granted Celgene an exclusive license to pinometostat outside of the U.S.